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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, monitoring (w/wo alarm)
510(k) Number K800086
Device Name RMS 111F RESPIRATORY MONITORING SYSTEM
Applicant
THE PERKIN-ELMER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
THE PERKIN-ELMER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1850
Classification Product Code
BZK  
Date Received01/14/1980
Decision Date 05/08/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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